ongoing review

OUR SERVICES

HOW YOU CAN PREPARE

Amendment Reviews

The IRB requires amendments to describe any modifications to an approved study, including reasons for the change, whether the information will increase or decrease the risk of harm to participant(s), and whether the consent form requires updating.

Amendments may be submitted for one or multiple sites, as applicable. If the study is utilizing the ERICA site-control model, participating site investigators can submit site-specific amendments. The UU IRB may need to consider applicable site-specific details before approving an amendment.

• Review the guidance on Submitting an Amendment in ERICA
  
  
• Acquire tracked copies of any changed documents (e.g., consent form, protocol, etc.)
  
  
• If applicable, review the instructions and features for the Site-Control Model

Continuing Reviews

The IRB requires renewal applications in order to review the progress for all participating sites and determine if a study may continue. This application should include information about current enrollment, ongoing enrollment, adverse events, withdrawals, study progress, and any amendments/changes. Continuing Review applications should be submitted eight weeks prior to the study expiration date.

No new forms or documents will be reviewed or approved without an amendment application. An Amendment may be submitted and reviewed in conjunction with a Continuing Review application.

If the study is utilizing the ERICA site-control model, participating site investigators can submit their site-specific continuing review information independently. This site-specific information may be included with the main study continuing review application for consideration together.

If a participating site fails to provide the needed continuing review information to be considered with the main study review, their site may “expire” while the rest of the study receives review and approval. The IRB will then review the site-specific continuing review application separately, once it has been submitted.

• Review the guidance on Submitting a Continuing Review in ERICA
  
  
• Determine if any amendments need to be submitted with the Continuing Review application.
  
  
• Gather continuing review information from each participating site (i.e., enrollment, current progress, any possible issues that have arisen, etc.)
  
  
• If applicable, review the instructions and features for the Site-Control Model

Report Form Reviews for Problems & Events

A report form application should be submitted in ERICA any time a reportable problem or event occurs at any of the sites for which the UU IRB serves as the IRB of record. Types of issues may include unanticipated problems or events, deviations, breaches of confidentiality, etc. In the report form, affected site(s) should be identified.

Reportable events must be submitted to the IRB promptly, within 10 days from the time the investigator learns of the information (5 days for research involving the VA). Late reports may be reviewed for additional non-compliance.

Once submitted, the report may be reviewed administratively or by the full board to determine if it meets the criteria for an Unanticipated Problem or Serious and/or Continuing Non-Compliance. The IRB will issue a notification in ERICA describing its determination and outline any necessary corrective and preventative actions.

It is the responsibility of participating site study teams to determine if their HRPP has local reporting requirements in addition to reporting to the SIRB when an event/problem occurs at their site. The UU IRB may need to work with a participating site’s HRPP to determine the best course of action to address the reported issue, including notification of applicable entities once a determination has been made (e.g., OHRP, FDA).

• Review guidance on Report Forms, including Unanticipated problems or events and Deviations to determine if the event is considered “reportable”
  
  
• Submit Report Forms only from the main study workspace, not from site-controlled applications.
  
  
• Only attach documents to Report Form applications that do not require approval; documents needing approval should be submitted as part of an Amendment.

Investigator Self-Assessments

A lead site or participating site study team may use the UU IRB’s self-assessment tools to perform internal monitoring to ensure research is being conducted properly.

• Use the Self-Assessment worksheet(s) to determine areas for study improvement
  
  
• If reportable issues are identified during a self-assessment, they must be submitted via a Report Form in ERICA.

Routine and For-Cause Auditing

The UU IRB has the authority to conduct routine and for-cause auditing for any participating site which it serves as the SIRB. The participating site’s institution also maintains the ability to conduct its own routine and for-cause auditing, even if they are relying on UU SIRB. An audit may be conducted at any time, with or without prior notice to the study team. If the UU IRB deems an audit necessary, we will work together with the site’s institution to determine who will carry out these duties. This may be delegated to UU IRB staff, participating site institution, or an independent auditor.

• Use the Self-Assessment worksheet(s) to determine areas for study improvement prior to an audit
  
  
• If reportable issues are identified during an audit— regardless of which institution conducted the audit — they must be submitted via a Report Form in ERICA.

Final Project Reports for Study Closure

After a study is finished at all sites, the Responsible PI submits a Final Project Report to provide the UU IRB with the final progress of the study, including:

• Total number of participants
• Amendments since last approval
• Problems and participant withdrawal, as applicable
• Study results, if available
• Sponsor/accounting information

Final Project Reports are submitted using the Continuing Review application in ERICA. You must indicate the study is ready to close in order for the application to take you to the Final Project Report. When prompted, answer “yes” to indicate a Final Project Report is being submitted and complete the remaining pages of the application.

If individual sites are requesting site closure, submit a Continuing Review application in advance of expiration and indicate which site(s) is closing.

• Review the criteria for when and how to submit a Final Project Report
  
  
• Gather final progress information from each participating site to include in the Final Project Report application.